DSM Project Manager - North Carolina - 6 Months Contract
Our client, a global pharmaceutical manufacturing organization are looking for a talented DSM Project Manager to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.
Essential Duties and Responsibilities for this role include, but are not limited to:
1. Coordinate project execution with engineering design firm, FDBN CAPEX team, FDBN Automation process area owners, and system integrator.
2. Manages delivery of specification documents (e.g., platform requirements specification (PRS), functional specification (FS), design qualification (DQ), etc.) and test protocols (e.g., installation qualification (IQ), operational qualification (OQ), etc.)
3. Initiate design and provide input on Automation requirements for one or multiple process areas
4. Manage/oversee the System Integrator’s support of loop checks & commissioning activities
5. Provide on-call support to Commissioning, Qualification, Validation, and Operations activities.
6. Coordinate with various project workstreams including FDBN Automation, FDBD Automation, CSV, CQV, Utilities, Process Engineering, Manufacturing, and others as needed
7. Complete Safety, Project Procedure, and Project Instruction training as required
Requirements:
1. Personal ownership and proactive collaboration with external business partners and internal stakeholders
2. Direct experience working with Emerson Delta V DCS & Delta V MES
3. Experience in a cGMP pharmaceutical facility working with FDA regulations is required
4. Working knowledge of Kneat validation software is required
5. Excellent organizational, oral, and written communication skills and fluency in English with the ability to effectively communicate within cross-functional teams and to management
6. Excellent interpersonal skills and ability to work effectively and efficiently in a team-based environment with employees at all levels
7. Ability to manage commitments while displaying an eagerness to learn and continuously improve
8. Knowledge of Drug Substance Manufacturing (DSM) process
9. Compliance Wire, Track Wise, and Veeva experience is a plus
If you are interested, please apply now for immediate consideration and further information.
